WAVRE, Belgium — 12 January 2022: iSTAR Medical, a medtech company delivering breakthrough eye care solutions to patients, today announced initial positive progress of MINIject™ in its US STAR-V trial. MINIject is a potentially best-in-class minimally-invasive glaucoma surgery (MIGS) implant and the only commercially available supraciliary MIGS device. The trial is now initiated in 13 sites across the US with positive feedback on initial implantations from world-leading glaucoma surgeons.
MINIject has demonstrated meaningful and enduring intraocular pressure (IOP) reduction, combined with a favorable safety profile, in completed and ongoing trials conducted in Europe, the Americas and Asia in over 150 patients so far.
The STAR-V trial is a US FDA-approved pivotal study assessing the safety and efficacy of MINIject in over 350 patients with primary open-angle glaucoma across the US, Canada and Europe. Following the trial’s FDA IDE approval in 2021, patient enrollment has been progressing as planned.
Glaucoma specialist Dr Steven D. Vold, from Vold Vision in Fayetteville, AR (USA), a long-standing contributor to ophthalmic device development and STAR-V trial investigator commented:
Dr Brian E. Flowers, a glaucoma specialist at Ophthalmology Associates at Fort Worth, TX (USA), and one of the investigators in STAR-V, said:
Dr. William J. Flynn, MD, from Eye Associates Research in San Antonio, TX (USA), expressed:
Michel Vanbrabant, CEO of iSTAR Medical, commented:
About iSTAR Medical
iSTAR Medical is committed to delivering breakthrough eye care solutions. Our most advanced product, MINIject, is approved in Europe for the treatment of open-angle glaucoma – the leading cause of irreversible blindness – and we are aiming to seek market approval in the US. We believe MINIject’s unique tissue-integrating capabilities unlock a safer, and more effective option for patients. We are building an exceptional team and pipeline of best-in-class products such as MINIject to establish new treatment paradigms in eye care conditions with the highest patient needs. For more information, please visit: www.istarmed.com
MINIject is iSTAR Medical’s innovative MIGS device for patients with primary open-angle glaucoma. MINIject combines the unique porous structure of its proprietary STAR material with the power offered by the supraciliary space. As a result, it is designed to enhance natural fluid outflow, reducing intraocular pressure (IOP) and the need for medication, while bio-integrating with surrounding tissue, limiting inflammation, fibrosis and subsequent complications.
Glaucoma is a progressive disease affecting over 100 million people globally, of which primary open-angle glaucoma is the most common form. IOP reduction, through medication or surgery, helps delay disease progression.Medication is generally the first line treatment, but the progressive addition of multiple drops can burden patients with side effects, compliance challenges and costs. Invasive surgery can present risks with irreversible complications and often requires long-term patient management. MIGS is the most promising and fastest-growing glaucoma therapy due to its enhanced safety profile. MINIject is potentially best-in-class for its promising long-term efficacy and safety.
 Jonas JB, Aung T, Bourne RR et al. “Glaucoma”. Lancet 2017; 390: 2083–93
 Market Scope, “2021 Glaucoma Surgical Device Market Report”, July 2021. https://www.market-scope.com/pages/reports/267/2021-glaucoma-surgical-device-market-report